Program to Promote Use of Generic Drugs in Japan

Transcription

1 Program to Promote Use of Generic Drugs in Japan March 22, 2012 CPhI Japan 2012 Tsuyoshi Matsuno Economic Affairs Division, Health Policy Bureau, Ministry of Health, Labour and Welfare * A Japanese translation is the official edition.

2 (trillion yen) National healthcare expenditure as percentage of national income Trend of healthcare expenditure 9.9% (Reference) Total healthcare expenditure as percentage of GDP 7.0% National healthcare expenditure (trillion yen) National healthcare expenditure as percentage of GDP Pull up of geriatric treatment-qualifying age 70 years -> 75 years (to Sep 2002) (since Oct 2007) Latter-stage elderly people healthcare expenditure (trillion yen*) * ( ): Rate of geriatric healthcare expenditure in national healthcare expenditure <Increase rate from previous fiscal year> (Medical fee revision) 0.2% 2.7% 1.0% 3.16% 0.82% Implementation of nursingcare insurance system (Major system revision> Thorough 30% burden of 30% burden of the elderly Introduction of 10% burden of implementation of 10% employees with high income of the the elderly burden of the elderly level of working people Expanded burden relief measure for infant patients (< 3 years -> preschool children) 1985 (S60) 1990 (H2) 1995 (H7) 2000 (H12) 2001 (H13) 2002 (H14) 2003 (H15) 2004 (H16) 2005 (H17) 2006 (H18) 2007 (H19) 2008 (H20) 2009 (H21) National healthcare expenditure Latter-stage elderly people healthcare expenditure National income GDP (fiscal year) (prospective result) Note 1 National income and GDP: national economic accounting (Dec 2009). The total healthcare expenditure is the healthcare expenditure used on comparing the healthcare expenditures of OECD countries and has a wider range than the national healthcare expenditure since preventive services, etc. are included. In 2008, the healthcare expenditure is 9.0% of GDP in average in the OECD countries. Note 2 The national healthcare expenditure and the latter-stage elderly people healthcare expenditure in fiscal 2009 are the prospective results calculated by multiplying each value in fiscal 2008 by the increase rate. The increase rate from the previous fiscal year in 2009 is the increase rate of approximate healthcare expenditure (%)

3 Meaning of use promotion of follower drugs (generic drugs) In the current situation where the healthcare expenditure is increasing, the efforts to reduce the supply costs by promotion of efficiency, etc. are necessary with securing the necessary services and aiming at quality maintenance / improvement * What is generic drug? A generic drug is a drug which contains the same active ingredient at the same content, which is administered through the same route, which has basically the same indication and which is used with the same dosage and administration as the forerunner drug. Therefore, a generic drug is equivalent to the forerunner drug in efficacy and safety and can be positioned as an interchangeable drug. By promoting use of generic drugs, (1) each patient s self burden of drug expense can be reduced (2) more efficient healthcare can be achieved without deteriorating the quality of healthcare.

4 Program for improvement of quality and efficiency of healthcare / nursing-care us gca services (summary) Effort Major goal/target Policy measures (2) Viewpoint of improving quality and efficiency of services 8.Use promotion of follower drugs To increase the share of follower Thorough instructions to follower drugs (16.8% on the amount base in drug manufacturers about fiscal 2004) to 30% or more information provision and stable (doubling from the present) by supply, information provision and fiscal 2012 enlightening gto people p and healthcare professionals about equivalency to forerunner drugs, etc. Investigation of effective measures for use promotion based on the results of checking the effect of prescription format change Thi i l d d i L B d P li 2007 d d id d t th This program was included in Large-Boned Policy 2007 and decided at the Cabinet Meeting in June 2007.

5 Dissemination of generic drugs (follower drugs) Consciousness of healthcare professionals (1) Healthcare professionals are generally uneasy about the quality and stable supply and do not feel sufficient necessity of using generic drugs in place of familiar forerunner drugs. (2) Burden of assortment of many products at pharmacy, difficulty in selection of generic drugs (for a certain antihypertensive drug, 34 companies are supplying generic drugs) Consciousness of patients (1) Awareness of generic drugs has been improved to some extent. (2) There is a merit of lower drug expenses for patients. But, on the other hand, a sufficient feeling of security that familiar forerunner drugs can be safely switched to follower drugs has not been obtained from healthcare professionals. Major countermeasures Goal: Achievement of 30% amount share of generic drugs by fiscal 2012 (22.8% as of September 2011) (1) Measures mainly targeting medical institutions and pharmacies (2) Measures mainly targeting patients Action program for promotion of easy-mind use of follower drugs (Specific efforts related to environment arrangements for securement of stable supply, quality and information provision system and use promotion) Environmental arrangement related to medical fee (Gradual appreciation of pharmacies depending on the amount rate of prescribed follower drugs and environment arrangement for prescription switching, appreciation of medical institutions i i using follower drugs proactively, insurance physicians i obligation i to check patient s intention i to select follower drugs, etc. Disclosure of list of follower drugs adopted at National Hospital Organizations Holding of generic drug easy-mind use promotion seminar Delivery of generic drug-wishing card Notification of cost difference on switching to generic drugs Publicity activities by preparation and delivery of posters and leaflets, etc.

6 Action program for promotion of easy-mind use of follower drugs (outline) Toward the government s goal of 30% or more amount share of follower drugs (doubling from the present percent) by fiscal 2012, the efforts to be made by the Government shall be clarified in relation to (1) stable supply, (2) quality securement, (3) information provision by follower drug manufacturers, (4) environment arrangement for use promotion and, (5) items related to healthcare insurance system so that patients and healthcare professionals can use follower drugs with easy mind. (1) Stable supply Opinion from clinical practice site Example: The time from order to delivery is sometimes long. Government Follower drug manufacturer Thorough instructions for stable supply Reception of complaints from healthcare professionals, disclosure of instructions to manufacturers, etc. Shortening the time until delivery 100 % delivery to wholesalers by the next day (within fiscal 2007) In a case of no stocks at wholesalers, 75% delivery to wholesalers within the day (within fiscal 2008) Stock securement In-house stock / distribution stock: At least one-month portion (within 2007) fiscal 2009) Zero products out of stock (within (2) Quality securement Opinion from clinical practice site Example: Some follower drugs may be different from the forerunner drug in dissolution and blood concentration achieved. Government Follower drug manufacturer Test/analysis conduct and result disclosure related to follower drug quality Conduct of impurity test targeting injectable preparations Collection and assortment of research articles related to follower drug quality, investigations of qualityrelated opinions presented to the Follower Drug Consultation Window, and the conduct of test/analysis as necessary Expansion of simultaneous vigilance/instruction and result disclosure GMP-based instruction through on-site inspection by Prefectural Government and Central Government Expansion of products designated for testing Quality test/analysis conduct and result disclosure By-batch conduct of product test (within fiscal 2007) Also the tests not required as conditions for approval (such as long-term storage test) are to be started, if not started yet, within the fiscal year (within fiscal 2007). Survey of relevant literatures The industry association shall survey and evaluate the follower drug-related literatures and take necessary measures (within fiscal 2007).

7 (3) Information provision by follower drug manufacturer Opinion from clinical practice site Example: No MR s visits Relying on the forerunner manufacturer for information provision i like saying Ask the forerunner manufacturer Government Follower drug manufacturer Instructions toward improvement of package insert The package insert shall describe additives, bioequivalence study data, stability study data, contact information for asking literatures, t etc. Revision by the end of March > Follower drug manufacturers shall finish by December Instruction toward reinforcing the information provision system of follower drug manufacturer Reinforcing the system to assort and evaluate the research and development data, collected ADR information and relevant literatures and provide information healthcare professionals Information provision to healthcare professionals Posting the test data, ADR data, etc. in the home page, prompt responses to requests for materials (within fiscal 2007) (4) Environment arrangement for use promotion Government Follower drug manufacturer Set-up of prefecture-level committee To set up a committee consisting of healthcare professionals and prefectural government officers for preparation/dissemination/enlightenment of use promotion measures at prefecture level Dissemination and enlightening with posters and pamphlets Preparation and delivery of posters and pamphlets for healthcare professionals and people (from fiscal 2007) Delivery of Generic Drug Q &A to medical institutions / newspaper advertisement of it (5) Items related to healthcare insurance system Appreciation of prescription including a follower drug in medical fee (from fiscal 2002) Previous efforts Appreciation in dispensing fee in a case where a follower drug is dispensed under the agreement of the patient obtained after providing the information on follower drug quality in addition to the information on the price difference between the forerunner drug and the follower drug to the patient in writing (from fiscal 2006) The prescription format was revised again to enable prescribing a follower drug in a case where there is no signature of physician in the box of No change allowed (from fiscal 2008). At pharmacy, gradual appreciation in dispensing fee depending on rate of prescribed amount of follower drugs (from fiscal2010) At medical institution, appreciation in medical fee in a case where the system to use follower drugs proactively is established (from 2010) The MHLW ordinances, etc. specified insurance pharmacist s obligations to make explanations related to follower drugs to patients and make efforts to dispense follower drugs as well as insurance physician s obligation to check patient s intention to use a follower drug (from 2010)

8 Conduct status of Action program for promotion of easy-mind use of follower drugs (summary) July For the major items raised in the Action program for promotion of easy-mind use of follower drugs (enacted on October ), the conduct status is shown below (as of the end of March 2011) For the effort items of follower drug manufacturers, the conduct status at each member company of the Japan Generic Medicines Association (JGMA) was summarized under cooperation of JMGA (number of target companies: 43, survey period: April to March ) Efforts of follower drug manufacturers Effort item Effort content in the action program Conduct status table supply St Shortening the time until delivery In case of no stock at wholesaler, 75% within-day delivery to the wholesaler (end of fiscal 2008) Number of events needing urgent delivery: 826 Among those, number of events with successful within-day delivery: 820 (99.3%) Occurrence of out of stock 6 companies, 14 events (accumulation in 1 year) Stock securement Zero products out of stock (end of fiscal 2009) * The number of events of out of stock is decreasing surely (2008: 14 companies, 34 events; 2009: 10 companies, 22 events), but further efforts will be made toward achievement of the goal. securement Quality s Conduct of quality test, etc. Securement of dissolution at the time of quality reevaluation The tests not required as conditions for approval (such as longterm storage test) are to be 100% started, if not started yet, within the fiscal year and the test results are to be provided per request of healthcare professionals, etc. (end of fiscal 2007) Number of products to be subjected to long-term storage test 5,177 products (all started) Among those, number of products for which the test was finished 3,064 products (59%) Number of products to be subjected to stability test in non-packaged state 3,149 products (all started) Among those, number of products for which the test was finished 3,089 products (98%) For the products designated to undergo quality reevaluation, it Number of products to be subjected to quality reevaluation 1,892 products will be confirmed periodically that the dissolution profile of such Among those, number of products for which dissolution profile was confirmed 1,881 products (99%) product is equivalent to that of the standard preparation for Among those, number of products for which dissolution profile is being confirmed 11 products (1%) quality reevaluation, and the test results will be provided promptly per request of healthcare professionals. Inform mation provi sion Information provision to healthcare professionals For interview form and compounding change test data, to secure prompt responses to requests for materials including posting in the company s own home page (end of fiscal 2008) For 8 information items raised in the action program including the interview form and compounding change test data, 100% information provision system was secured for material requests from healthcare professionals. Operation of Generic Drug Information Provision System was started, and the system enabling prompter and smoother information provision was secured. Efforts of government Item related to quality securement Effort item Conduct of tests related to impurities contained in injectable preparations among follower drugs, collection and assortment of research articles related to follower drug quality, and conduct of necessary tests/analyses Conduct status Based on the quality-related research articles, dissolution tests were conducted at the National Institute of Health Sciences and others, and the test results were announced in the home page. Environment arrangement related to use promotion Preparation of posters and others contributing to Public announcement through the government internet television dissemination of follower drugs Committees were set up in 42 prefectures, and deliberations and efforts related to use promotion of follower drugs Enactment of use promotion measures at the prefecture were performed. level About the examples of advanced efforts in prefectures, the contents and effects were surveyed and studied. Promotion of sharing the follower drug list used at the district level, among healthcare professionals In 11 prefectures, the Follower Drug Adoption Know-How Dissemination Program was performed to share the follower drug adoption standards in each district.

9 [(1) Stable supply ] Example efforts related to stable supply Shortening the time to delivery (Goal : At least 75% delivery within the day by March 2009) Latter half of fiscal 2007(the first fiscal year of the action program) Rate of within-day delivery among the requests for urgent delivery % Fiscal 2010: Improved to 99.3%! To eliminate products out of stock (Goal : Zero products out of stock by March 2010) Latter half of fiscal products of 9 companies (in a 6-month period) Fiscal products of 6 companies (in 12-month period)

10 [(1) Stable supply ] Major examples of out of stock seen actually (1) Injectable Preparation A (Cause) There was a flaw in data management of laboratory at the overseas manufacturing site, and product release was voluntarily stopped until the completion of investigation. => (Major preventive measure) Grasping the data management status of the (Duration of no supply) About one month overseas manufacturing site and close communication/coordination (2) Tablet Preparation B (Cause) The same as Injectable Preparation A (Duration of no supply) About three months => (Major preventive measure) Grasping the data management status of the overseas manufacturing site and close communication/coordination (3) Injectable Preparation C (Cause) The order volume exceeded the capacity of freeze-drying machine. (Duration of no supply) About half month => (Major preventive measure) Establishment of inhouse liaison system (4) Capsule Preparation D (Cause) Approval was delayed due to a flaw in procedures to change the drug product manufacturing site. (Duration of no supply) About half month => (Major preventive measure) Action on changing the approval contents (5) Slow-release Tablet Preparation E (Cause) Difficulty in obtaining raw materials (Duration of no supply) About half month => (Major preventive measure) Securement of alternative supply source for raw materials (6) Ophthalmic Solution F (Cause) Delay of manufacturing due to component breakdown of manufacturing equipment (Duration of no supply) About half month => (Major preventive measure) Maintenance/inspection of manufacturing facility When an alternative product of another company is available, the ordering party shall make arrangements to promptly secure the alternative product before falling in the state of out of stock.

11 [(1) Stable supply ] Countermeasures toward stable supply Efforts of Japan Generic Medicines (JGA) Set-up of Product Inventory Manager Liaison Committee Measures to secure stable supply of raw materials such as drug substance Disclosure of information on supply Posting the effort-taking status in the home page of JGA Disclosure of information on supply of each product Exemplification of events easily resulting in out of stock Preparation and revision of Points to Consider for prevention of out of stock (From the material a prepared ed by JGA)

12 [(2) Quality securement] Opinions related to generic drug quality expressed at the meeting of Central Social Insurance Medical Council It is all that we request the MHLW to make further efforts to secure the follower drug quality at the same level as the forerunner drug quality. Physicians are concerned about the quality of follower drugs. Some patients say that if the quality is equivalent, a lower price is better. The problem in follower drugs is efficacy. Since the efficacy is not sufficiently examined, 31% of physicians have a sense of distrust. The final difference in stability due to difference in solid-phase synthesis may result in by-batch differences and data showing ineffectiveness in spite of the equivalent results obtained at the time of approval. Physicians will be convinced of the quality if the data are presented in comparison with non-active substance. We would like the MHLW to sufficiently ypresent correct data of equivalency and quality. The number of problematic cases handled at the meeting of Japanese Society of Clinical Pharmacology and Therapeutics is also decreasing. If there is a problem with follower drugs, it may be good for us to receive explanations on each occasion. It is difficult to scientifically show the rate of follower drugs doubted in efficacy since clinical studies are necessary. When even one follower drug gives bad impression, physicians will have bad impression about the entire follower drugs. How about making the follower drug manufacturer describe that the contained excipient is not the same between this drug and the forerunner drug in the package insert of the follower drug.

13 [(2) Quality securement] Quality securement by conduct of test/analysis of generic drugs General people Medical institution / university / pharmaceutical company Physician/pharmacist onsultation /test results, nt of major co nes of survey c. in internet Announcemen ontents, outlin etc A co PMDA MHLW Consultation Window Concerns about follower drug quality Conduct of test/analysis to dispel distrust in follower drug Presentation at academic meeting, published article Test/analysis of impurities in drug substance for injectable preparation, etc. Collection/evaluation of research articles, etc. National Institute of Health Sciences Generic Drug Quality Information Conference Generic drug quality information Drug Consultation Window p jy Evaluation of collected information Selection of products to be tested Evaluation of test results Local Institute of Health Sciences Consisting of about 10 members selected from universities, medical associations and pharmacist associations, pharmaceutical companies Conduct of test Scientific analysis, test/examination, evaluation => Formation of trust basis

14 [(3) Information provision by generic drug manufacturer ] Generic Drug Information Provision System of JGA People / patients Healthcare professionals Information search Inquiry Request for material Information provision Access to each company s site Material forwarding Response to question Generic Drug Information Provision System JGA j Automatic transfer of material request / question Internet connection Data inputting Each member company Copyright 2008 Japan Generic Medicines Association All Rights Reserved.

15 Changes of generic drug market share 25.0% 22.8% Unit: % 20.0% 15.0% 16.8% 18.7% 20.2% 2% Amount base 10.0% 8.8% Money base 50% 5.0% 5.9% 6.6% 7.6% 0.0% Sep.'05 Sep.'07 Sep.'09 Sep.'11 Survey by MHLW

16 Goal of generic drug use promotion Sep 2007 Drug price survey (amount share) Forerunner drugs (without follower drug) 21.6% Forerunner drugs (with follower drug) 34.9% Follower drugs Other drugs 18.7% 24.8% Fiscal 2012 Goal (amount share) 30.0% At leas 50% of drugs which h can be switched to generic drugs * Other drugs: Drugs approved in or before 1967, Kampo extract preparations, crude drugs, biological preparations (vaccines, blood preparations), JP drugs

17 Environment arrangement for use promotion of follower drugs (outline) Detailed contents 1 Review of premium for follower drug dispensing system in basic dispensing fee of insurance pharmacy The requisite for premium, i.e., use rate of follower drugs (amount base) will be changed from the conventional not less than 20%, not less than 25% and not less than 30% to not less than 22%, not less than 30% and not less than not less than 35%, and the appreciation rate will also be graded. 2 Information provision related to follower drugs utilizing the Drug Information Provision Sheet When the information on follower drugs (presence/absence, prices and inventory information of follower drugs) is provided with the Drug Information Provision Sheet at a pharmacy, appreciation will be made in the pharmaceutical management fee. 3 Appreciation of the system to proactively use follower drugs at medical institutions To the conventional requisite for premium (numerical rate of follower drugs in adopted drugs: not less than 20%), appreciation of not less than 30% will be added. 4 Promotion of prescription with nonproprietary name, change of prescription format, etc. To promote prescription with nonproprietary name, when physicians issue prescriptions. To change the current prescription format so that it can be shown clearly for each drug whether switching to a follower drug is allowed. 5 Quality securement of follower drugs (1) To prepare scientific opinions on follower drugs for healthcare professionals and people (2) To make proactive information provision for the discussion results at the Generic Drug Quality Information Conference (Prepared according to the handouts at the meeting of Central Social Insurance Medical Council held on Dec )

18 Information provision related to follower drugs utilizing the Drug Information Provision Sheet Conventional problems The Notification of cost reduction by using generic drug performed by the insurer has shown a certain level of effect, but the number of patients receiving it actually is still small. As the trigger which actually drove the patients to switching to follower drugs, the explanations by the pharmacists and the advertisements of follower drugs account for a high rate. On the other hand, some of the patients who wish switching to follower drugs at a pharmacy do not know that there are no generic drugs for the drug concerned or that a follower drug has already been prescribed. New Countermeasures As the measure to improve information provision related to follower drugs, the information provision utilizing the Drug Information Provision Sheet handed to patients at an insurance pharmacy will be appreciated as a requisite for premium in dispensing fee. The information related to follower drugs includes the following: (1) the presence/absence of follower, (2) price, (3)inventory information

19 Promotion of prescription with nonproprietary name In order to further promote use of follower drugs and reduce the burden of stock management of follower drugs at an insurance pharmacy, a new premium will be set for physician s prescription with the nonproprietary name issued for drugs with follower drugs. Current system Proposed revision [Prescription fee] 1 A case where 7 or more kinds of drugs are administered (except drugs administered transiently for less than two weeks) 40 points [Prescription fee] 1 A case where 7 or more kinds of drugs are administered (except drugs administered transiently for less than two weeks) 40 points 2 Other than 1 above 68 points 2 Other than 1 above 68 points (Addition of Note) In a case where a prescription including a nonproprietary name is issued, 2 points will be added for each issue of the prescription.

20 Rate of follower drugs having a brand name based on the nonproprietary name (Survey by Japan Generic Medicines Association) Among the follower drugs in medical fee, the rate of those having a brand name based on nonproprietary name is increasing, being 38% at present. As of June 2008 Unified name 2% Combination drug 8% Nonproprietary name 20% As of October 2011 Unified name 5% Combination drug 7% Nonproprietary name 38% Brand name 70% June 2008 October 2011 Number of Number of Share products products Share Nonproprietary name 1,324 20% 2,946 38% Brand name 4,687 70% 3,835 50% Unified name 110 2% 404 5% Combination drug 570 8% 530 7% Total 6, % 7, % Brand name 50%

21 Social Security / Tax Integrated Reform Draft (Extract) (Decided on January by Government / Ruling Party Social Security Reform Headquarter) Chapter 3 Specific Reform Contents (Reform Item and Process) 3. Healthcare nursing-care (2) (Reinforcement of safety net function of healthcare /nursingcare insurance through reinforcement of insurer function and benefit prioritization, low- income class measures) (9) Further promotion of use of follower drugs, review of patient s burden of drug cost, etc. To prepare p a road map for promotion of follower drugs and take comprehensive measures for use promotion such as appreciation in medical fee calculation, information provision to patients, change of prescription format, quality securement for improved confidence of healthcare professionals. In addition, to reduce the prices of forerunner drugs with follower drugs with giving gconsideration to the viewpoint of innovation. As for the review of patient s burden of drug cost, make deliberations based on To review patient s burden of drug cost taking consideration the price levels of marketed drugs described in the Social Security / Tax Integrated Reform Draft.

22 To promote use of generic drugs It is important for both healthcare professionals and people to place confidence in generic drugs and have a mind to proactively use generic drugs through the following efforts: (1) securement of reliability of generic drugs in the aspects of quality, stable supply and information provision, and thorough notification thereof (2) appreciation in calculation of medical fee and dissemination/enlightenment from insurers to the insured

23 Thank you! Central Joint Government Building No. 5 (MHLW)